Einwilligungsmanagement

Die digitale Einwilligung stellt den Bezug von Patient und der menschenlesbaren Repräsentation der für den Patienten relevanten Einwilligungs- und Widerrufsdokumente her.

Aus technischer Sicht sind unterschiedliche Umsetzungen von Consent-Ressourcen auf Basis dieser ausgefüllten Dokumente (QuestionnaireResponse-Ressourcen) möglich.

Die Entscheidung, welche Variante (Ergebnis-Typ) umgesetzt wird, ist vom spezifischen Use-Case abhängig und Teil der Implementierung:

Ergebnis-Typ	Code	Erzeugung einer Consent-Ressource …	Aggregat von Informationen	Anwendungsbeispiel
Dokument	`document`	je QuestionnaireResponse	Nein	Ausleitung von ausgefüllten Einwilligungsdokumenten in der MII. Erzeugung aus der QuestionnaireResponse Ressource (Mapping aller Fragen auf entspr. Policies)
Modul	`module`	je TemplateModule (ggf. mit 1-n Fragen) einer QuestionnaireResponse	Nein	Ausleitung IHE APPC (1-n) PolicySets zum Beispiel für Modul Bioproben. Erzeugung aus der QuestionnaireResponse Ressource (Mapping ausgewählter, inhaltlich zusammenhängender Fragen auf entspr. Policies)
Policy	`policy`	je sich aus dem QuestionnaireResponse ergebender zulässiger Handlung (Policy)	Nein	Ausleitung von SignedPolicies im gICS. Erzeugung aus der QuestionnaireResponse Ressource (Mapping aller Fragen auf entspr. Policies. Je Policy wird eine Consent-Ressource erzeugt.)
Einwilligungsstand	`consent-status`	je Patient und Forschungsvorhaben. Dabei werden alle für den Patient relevanten Einwilligungs-und Widerrufsdokumente berücksichtigt und der somit geltende Einwilligungsstand errechnet	Ja, Zeitpunkt der Abfrage bzw unter Angabe eines Zeitpunkts. Berechnet auf Basis der aktuell bekannten Informationen	Ausleitung von Einwilligungsständen je Patient. Dieser kann sich über die Zeit durch mehrfache Einwilligungen und Widerrufe ändern. Erzeugung aus 1-3 nach aktuellem Kenntnisstand
Einwilligungsstand historisch	`consent-status-historical`	je Patient und Forschungsvorhaben. Dabei werden alle für den Patient zu einem gegebenen Zeitpunkt bekannten und relevanten Einwilligungs-und Widerrufsdokumente berücksichtigt und der somit zu diesem Zeitpunkt geltende Einwilligungsstand errechnet	Ja, Aggregat auf Basis des damals geltenden Wissensstands (z.B. als Beleg im Zuge der Nachweispflicht ggü. Aufsichtsbehörden)	Ausleitung von Einwilligungsständen je Patient. Dieser kann sich über die Zeit durch mehrfache Einwilligungen und Widerrufe ändern. Erzeugung aus 1-3 mit dem zum angegeben Zeitpunkt (Vergangenheit) gültigen Kenntnisstand.

Definition der Gültigkeit der Einwilligung mittels Provision

Grundsätzlich gibt eine Provision.period die Gültigkeitsdauer einer zugeordneten Regel (hier: die Einwilligung/der Widerruf/der Dokumentbestandteil) an.

Die grundsätzliche Gültigkeitsdauer der Consent-Ressource wird per consent.provision (Level1-Provision) definiert (z.B. 30 Jahre). Sollten einzelne Module oder Policies der Einwilligung jedoch bereits frühzeitig ablaufen, können diese Ausnahmen von der Gesamteinwilligungsdauer in Form untergeordneter Provisions (Level2-Provision) mit Bezug zum relevanten Dokumentbestandteil definiert werden (z.B. consent.provision.provision=5 Jahre). Auf diese Weise werden mit Hilfe der Consent.Provision Gültigkeitshierarchien erzeugt.

Einer Provision-Ressource können konkrete Datenelemente zugeordnet sein (Observation, etc.). Diese werden über consent.provision.data referenziert. Die Art der zulässigen Nutzung der Daten kann gemäß passendem consent.provision.provision.code (z.B. wissenschaftliche Nutzung, Weitergabe an Forschungseinrichtungen, etc.) festgelegt werden. Die zulässige Nutzungsdauer der Daten wird mittels consent.provision.dataPeriod eingeschränkt. Diese kann im Falle der Zulässigkeit von z.B. retrospektiven Datennutzungen ggf. bereits vor dem Zeitpunkt der Einwilligung beginnen.

ConsentManagementConsent (Consent)	I		Consent	There are no (further) constraints on this element Element id Consent Short description A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time Definition A record of a healthcare consumer’s choices, which permits or denies identified recipient(s) or recipient role(s) to perform one or more actions within a given policy context, for specific purposes and periods of time. Comments Broadly, there are 3 key areas of consent for patients: Consent around sharing information (aka Privacy Consent Directive - Authorization to Collect, Use, or Disclose information), consent for specific treatment, or kinds of treatment, and general advance care directives. Data type Consent Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource `contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()` dom-6: A resource should have narrative for robust management text.`div`.exists() dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` ppc-4: IF Scope=adr, there must be a patient `patient.exists() or scope.coding.where(system='something' and code='adr').exists().not()` ppc-5: IF Scope=treatment, there must be a patient `patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not()` ppc-2: IF Scope=privacy, there must be a patient `patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not()` ppc-3: IF Scope=research, there must be a patient `patient.exists() or scope.coding.where(system='something' and code='research').exists().not()` ppc-1: Either a Policy or PolicyRule `policy.exists() or policyRule.exists()` Mappings rim: Entity. Role, or Act workflow: Event v2: CON rim: FinancialConsent
id	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id Consent.meta Short description Metadata about the resource Definition The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id Consent.implicitRules Short description A set of rules under which this content was created Definition A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
language		0..1	codeBinding	There are no (further) constraints on this element Element id Consent.language Short description Language of the resource content Definition The base language in which the resource is written. Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
text		0..1	Narrative	There are no (further) constraints on this element Element id Consent.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id Consent.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels. Data type Resource Mappings rim: Entity. Role, or Act rim: N/A
extension	I	0..*	Extension	Element id Consent.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
domainReference	S I	0..*	Extension(Complex)	Element id Consent.extension:domainReference Short description Optional Extensions Element Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(Complex) Extension URL http://fhir.de/ConsentManagement/StructureDefinition/DomainReference Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id Consent.extension:domainReference.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	Element id Consent.extension:domainReference.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
domain	S I	1..1	Extension	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:domain Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:domain.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:domain.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
url		1..1	uriFixed Value	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:domain.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data type uri Fixed value domain Mappings rim: N/A
value[x]		1..1		There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:domain.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:domain.value[x].id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:domain.value[x].extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
reference	Σ I	1..1	string	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:domain.value[x].reference Short description Literal reference, Relative, internal or absolute URL Definition A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources. Comments Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
type	Σ	0..1	uriBinding	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:domain.value[x].type Short description Type the reference refers to (e.g. "Patient") Definition The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent. The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources). Comments This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified. Data type uri Binding Aa resource (or, for logical models, the URI of the logical model). ResourceType (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
identifier	Σ	0..1	Identifier	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:domain.value[x].identifier Short description Logical reference, when literal reference is not known Definition An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference. Comments When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it. Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation\|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any). Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier rim: .identifier
display	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:domain.value[x].display Short description Text alternative for the resource Definition Plain text narrative that identifies the resource in addition to the resource reference. Comments This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
valueReference			Reference(ConsentManagementDomainOrganization \| ConsentManagementDomainResearchStudy)	There are no (further) constraints on this element Data type Reference(ConsentManagementDomainOrganization \| ConsentManagementDomainResearchStudy)
status	I	0..1	Extension	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:status Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:status.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:status.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
url		1..1	uriFixed Value	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:status.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data type uri Fixed value status Mappings rim: N/A
value[x]		1..1	Binding	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:status.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Binding PublicationStatus (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
valueCoding			Coding	There are no (further) constraints on this element Data type Coding
id		0..1	string	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:status.value[x].id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:status.value[x].extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
system	Σ	1..1	uri	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:status.value[x].system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:status.value[x].version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	Σ	1..1	code	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:status.value[x].code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:status.value[x].display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id Consent.extension:domainReference.extension:status.value[x].userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
url		1..1	uriFixed Value	There are no (further) constraints on this element Element id Consent.extension:domainReference.url Short description identifies the meaning of the extension Definition Source of the definition for the extension code - a logical name or a URL. Comments The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. Data type uri Fixed value http://fhir.de/ConsentManagement/StructureDefinition/DomainReference Mappings rim: N/A
value[x]		0..0		There are no (further) constraints on this element Element id Consent.extension:domainReference.value[x] Short description Value of extension Definition Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id Consent.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
identifier	Σ	0..*	Identifier	There are no (further) constraints on this element Element id Consent.identifier Short description Identifier for this record (external references) Definition Unique identifier for this copy of the Consent Statement. Comments This identifier identifies this copy of the consent. Where this identifier is also used elsewhere as the identifier for a consent record (e.g. a CDA consent document) then the consent details are expected to be the same. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Examples General { "system": "urn:ietf:rfc:3986", "value": "Local eCMS identifier" } Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier workflow: Event.identifier w5: FiveWs.identifier rim: .id
status	S Σ ?!	1..1	codeBinding	There are no (further) constraints on this element Element id Consent.status Short description draft \| proposed \| active \| rejected \| inactive \| entered-in-error Definition Indicates the current state of this consent. Requirements The Consent Directive that is pointed to might be in various lifecycle states, e.g., a revoked Consent Directive. Comments This element is labeled as a modifier because the status contains the codes rejected and entered-in-error that mark the Consent as not currently valid. Data type code Binding Indicates the state of the consent. ConsentState (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a workflow: Event.status w5: FiveWs.status v2: HL7 Table 0498 - Consent Status rim: .statusCode
scope	Σ ?!	1..1	CodeableConceptBinding	Element id Consent.scope Short description Which of the four areas this resource covers (extensible) Definition A selector of the type of consent being presented: ADR, Privacy, Treatment, Research. This list is now extensible. Comments Wird im Kontext des Einwilligungsmanagment-Leitfadens nicht näher definiert. Bei Bedarf kann das ValueSet erweitert oder ggf. ein NullFlavor-Code eingetragen werden. Data type CodeableConcept Binding The four anticipated uses for the Consent Resource. ConsentScopeCodes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
category	S Σ	1..*	CodeableConceptBinding	Element id Consent.category Short description Classification of the consent statement - for indexing/retrieval Definition A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Sliced: Unordered, Open, by $this(Pattern) Binding A classification of the type of consents found in a consent statement. ConsentCategoryCodes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD workflow: Event.code w5: FiveWs.class v2: HL7 Table 0497 - Consent Type rim: CNTRCT
consentCategory	S Σ	1..*	CodeableConceptBinding	There are no (further) constraints on this element Element id Consent.category:consentCategory Short description Classification of the consent statement - for indexing/retrieval Definition A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding A classification of the type of consents found in a consent statement. ConsentCategoryCodes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD workflow: Event.code w5: FiveWs.class v2: HL7 Table 0497 - Consent Type rim: CNTRCT
id		0..1	string	There are no (further) constraints on this element Element id Consent.category:consentCategory.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.category:consentCategory.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
coding	S Σ	1..*	Coding	There are no (further) constraints on this element Element id Consent.category:consentCategory.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id Consent.category:consentCategory.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.category:consentCategory.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
system	S Σ	1..1	uri	There are no (further) constraints on this element Element id Consent.category:consentCategory.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.category:consentCategory.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	S Σ	1..1	code	There are no (further) constraints on this element Element id Consent.category:consentCategory.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.category:consentCategory.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id Consent.category:consentCategory.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.category:consentCategory.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
resultType	S Σ	0..*	CodeableConceptBinding	Element id Consent.category:resultType Short description Classification of the consent statement - for indexing/retrieval Definition A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding A classification of the type of consents found in a consent statement. ConsentManagementResultType (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD workflow: Event.code w5: FiveWs.class v2: HL7 Table 0497 - Consent Type rim: CNTRCT
id		0..1	string	There are no (further) constraints on this element Element id Consent.category:resultType.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.category:resultType.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
coding	S Σ	1..*	Coding	There are no (further) constraints on this element Element id Consent.category:resultType.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id Consent.category:resultType.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.category:resultType.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
system	S Σ	1..1	uri	There are no (further) constraints on this element Element id Consent.category:resultType.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.category:resultType.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	S Σ	1..1	code	There are no (further) constraints on this element Element id Consent.category:resultType.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.category:resultType.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id Consent.category:resultType.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.category:resultType.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
templateType	S Σ	0..*	CodeableConceptBinding	Element id Consent.category:templateType Short description Classification of the consent statement - for indexing/retrieval Definition A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding A classification of the type of consents found in a consent statement. ConsentManagementTemplateType (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD workflow: Event.code w5: FiveWs.class v2: HL7 Table 0497 - Consent Type rim: CNTRCT
id		0..1	string	There are no (further) constraints on this element Element id Consent.category:templateType.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.category:templateType.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
coding	S Σ	1..*	Coding	There are no (further) constraints on this element Element id Consent.category:templateType.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id Consent.category:templateType.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.category:templateType.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
system	S Σ	1..1	uri	There are no (further) constraints on this element Element id Consent.category:templateType.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.category:templateType.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	S Σ	1..1	code	There are no (further) constraints on this element Element id Consent.category:templateType.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.category:templateType.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id Consent.category:templateType.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.category:templateType.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
patient	S Σ I	1..1	Reference(Consent Management: Patient)	Element id Consent.patient Short description Who the consent applies to Definition The patient/healthcare consumer to whom this consent applies. Comments Commonly, the patient the consent pertains to is the author, but for young and old people, it may be some other person. Data type Reference(Consent Management: Patient) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.subject w5: FiveWs.subject[x] rim: Role w5: FiveWs.subject
id		0..1	string	There are no (further) constraints on this element Element id Consent.patient.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.patient.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
reference	Σ I	0..1	string	There are no (further) constraints on this element Element id Consent.patient.reference Short description Literal reference, Relative, internal or absolute URL Definition A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources. Comments Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
type	Σ	0..1	uriBinding	There are no (further) constraints on this element Element id Consent.patient.type Short description Type the reference refers to (e.g. "Patient") Definition The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent. The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources). Comments This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified. Data type uri Binding Aa resource (or, for logical models, the URI of the logical model). ResourceType (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
identifier	Σ	0..1	Identifier	There are no (further) constraints on this element Element id Consent.patient.identifier Short description Logical reference, when literal reference is not known Definition An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference. Comments When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it. Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation\|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any). Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier rim: .identifier
display	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.patient.display Short description Text alternative for the resource Definition Plain text narrative that identifies the resource in addition to the resource reference. Comments This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
dateTime	S Σ	1..1	dateTime	Element id Consent.dateTime Short description Erstellungszeitpunkt der Einwilligungsinformation Definition Zu diesem Zeitpunkt wurde diese Einwilligungsinformation erstellt. Dies ist nicht notwendigerweise identisch mit dem Zeitpunkt der Einwilligungserklärung oder dem Beginn des Gültigkeitszeitraums. Comments Dieser Zeitpunkt sollte in der Praxis, zumindest bei vollelektronischer Verarbeitung, identisch mit dem Unterschriftsdatum des Fragebogens sein (Provenance.signature.when des Patienten) Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a workflow: Event.occurrence[x] w5: FiveWs.recorded v2: Field 13/ Consent Decision Date rim: FinancialConsent effectiveTime
performer	Σ I	0..*	Reference(Organization \| Patient \| Practitioner \| RelatedPerson \| PractitionerRole)	There are no (further) constraints on this element Element id Consent.performer Short description Who is agreeing to the policy and rules Alternate names consentor Definition Either the Grantor, which is the entity responsible for granting the rights listed in a Consent Directive or the Grantee, which is the entity responsible for complying with the Consent Directive, including any obligations or limitations on authorizations and enforcement of prohibitions. Comments Commonly, the patient the consent pertains to is the consentor, but particularly for young and old people, it may be some other person - e.g. a legal guardian. Data type Reference(Organization \| Patient \| Practitioner \| RelatedPerson \| PractitionerRole) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.performer w5: FiveWs.actor v2: Field 24/ ConsenterID
organization	S Σ I	0..*	Reference(Organization)	Element id Consent.organization Short description Organisation, in der die Einwilligung erfasst wurde. Alternate names custodian Definition Dies ist die Organisation, die den Consent erfasst hat. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Organization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) workflow: Event.performer w5: FiveWs.witness
source[x]	S Σ	0..1		There are no (further) constraints on this element Element id Consent.source[x] Short description Source from which this consent is taken Definition The source on which this consent statement is based. The source might be a scanned original paper form, or a reference to a consent that links back to such a source, a reference to a document repository (e.g. XDS) that stores the original consent document. Comments The source can be contained inline (Attachment), referenced directly (Consent), referenced in a consent repository (DocumentReference), or simply by an identifier (Identifier), e.g. a CDA document id. Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: Field 19 Informational Material Supplied Indicator
id		0..1	string	There are no (further) constraints on this element Element id Consent.source[x].id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.source[x].extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
reference	S Σ I	1..1	string	There are no (further) constraints on this element Element id Consent.source[x].reference Short description Literal reference, Relative, internal or absolute URL Definition A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources. Comments Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
type	Σ	0..1	uriBinding	There are no (further) constraints on this element Element id Consent.source[x].type Short description Type the reference refers to (e.g. "Patient") Definition The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent. The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources). Comments This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified. Data type uri Binding Aa resource (or, for logical models, the URI of the logical model). ResourceType (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
identifier	Σ	0..1	Identifier	There are no (further) constraints on this element Element id Consent.source[x].identifier Short description Logical reference, when literal reference is not known Definition An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference. Comments When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it. Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation\|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any). Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier rim: .identifier
display	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.source[x].display Short description Text alternative for the resource Definition Plain text narrative that identifies the resource in addition to the resource reference. Comments This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
sourceReference			Reference(Consent Management QuestionnaireResponse)	Data type Reference(Consent Management QuestionnaireResponse)
policy	S	0..*	BackboneElement	There are no (further) constraints on this element Element id Consent.policy Short description Policies covered by this consent Definition The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Consent.policy.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.policy.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Consent.policy.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
authority	I	0..1	uri	There are no (further) constraints on this element Element id Consent.policy.authority Short description Enforcement source for policy Definition Entity or Organization having regulatory jurisdiction or accountability for enforcing policies pertaining to Consent Directives. Comments see http://en.wikipedia.org/wiki/Uniform_resource_identifier Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
uri	S I	1..1	uri	There are no (further) constraints on this element Element id Consent.policy.uri Short description Specific policy covered by this consent Definition The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law. Comments This element is for discoverability / documentation and does not modify or qualify the policy rules. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
policyRule	S Σ I	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id Consent.policyRule Short description Regulation that this consents to Definition A reference to the specific base computable regulation or policy. Requirements Might be a unique identifier of a policy set in XACML, or other rules engine. Comments If the policyRule is absent, computable consent would need to be constructed from the elements of the Consent resource. Data type CodeableConcept Binding Regulatory policy examples. ConsentPolicyRuleCodes (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
id		0..1	string	There are no (further) constraints on this element Element id Consent.policyRule.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	Element id Consent.policyRule.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
xacml	S I	0..1	Extension(base64Binary)	Element id Consent.policyRule.extension:xacml Short description Optional Extensions Element Alternate names extensions, user content Definition Optional Extension Element - found in all resources. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension(base64Binary) Extension URL http://fhir.de/ConsentManagement/StructureDefinition/Xacml Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
coding	Σ	0..*	Coding	There are no (further) constraints on this element Element id Consent.policyRule.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
text	Σ	0..1	string	There are no (further) constraints on this element Element id Consent.policyRule.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
verification	Σ	0..*	BackboneElement	There are no (further) constraints on this element Element id Consent.verification Short description Consent Verified by patient or family Definition Whether a treatment instruction (e.g. artificial respiration yes or no) was verified with the patient, his/her family or another authorized person. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Consent.verification.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.verification.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Consent.verification.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
verified	Σ	1..1	boolean	There are no (further) constraints on this element Element id Consent.verification.verified Short description Has been verified Definition Has the instruction been verified. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
verifiedWith	I	0..1	Reference(Patient \| RelatedPerson)	There are no (further) constraints on this element Element id Consent.verification.verifiedWith Short description Person who verified Definition Who verified the instruction (Patient, Relative or other Authorized Person). Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Patient \| RelatedPerson) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
verificationDate		0..1	dateTime	There are no (further) constraints on this element Element id Consent.verification.verificationDate Short description When consent verified Definition Date verification was collected. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
provision	S Σ	0..1	BackboneElement	There are no (further) constraints on this element Element id Consent.provision Short description Constraints to the base Consent.policyRule Definition An exception to the base policy of this consent. An exception can be an addition or removal of access permissions. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Consent.provision.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.provision.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Consent.provision.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
type	Σ	0..1	codeBinding	There are no (further) constraints on this element Element id Consent.provision.type Short description deny \| permit Definition Action to take - permit or deny - when the rule conditions are met. Not permitted in root rule, required in all nested rules. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Binding How a rule statement is applied, such as adding additional consent or removing consent. ConsentProvisionType (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
period	S Σ I	0..1	Period	There are no (further) constraints on this element Element id Consent.provision.period Short description Timeframe for this rule Definition The timeframe in this rule is valid. Comments A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See Duration. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` per-1: If present, start SHALL have a lower value than end `start.hasValue().not() or end.hasValue().not() or (start <= end)` Mappings rim: n/a v2: DR rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
actor		0..*	BackboneElement	There are no (further) constraints on this element Element id Consent.provision.actor Short description Who\|what controlled by this rule (or group, by role) Definition Who or what is controlled by this rule. Use group to identify a set of actors by some property they share (e.g. 'admitting officers'). Meaning when missing There is no specific actor associated with the exception Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id Consent.provision.actor.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.provision.actor.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Consent.provision.actor.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
role		1..1	CodeableConceptBinding	There are no (further) constraints on this element Element id Consent.provision.actor.role Short description How the actor is involved Definition How the individual is involved in the resources content that is described in the exception. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding How an actor is involved in the consent considerations. SecurityRoleType (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
reference	I	1..1	Reference(Device \| Group \| CareTeam \| Organization \| Patient \| Practitioner \| RelatedPerson \| PractitionerRole)	There are no (further) constraints on this element Element id Consent.provision.actor.reference Short description Resource for the actor (or group, by role) Definition The resource that identifies the actor. To identify actors by type, use group to identify a set of actors by some property they share (e.g. 'admitting officers'). Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Device \| Group \| CareTeam \| Organization \| Patient \| Practitioner \| RelatedPerson \| PractitionerRole) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
action	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id Consent.provision.action Short description Actions controlled by this rule Definition Actions controlled by this Rule. Comments Note that this is the direct action (not the grounds for the action covered in the purpose element). At present, the only action in the understood and tested scope of this resource is 'read'. Meaning when missing all actions Data type CodeableConcept Binding Detailed codes for the consent action. ConsentActionCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
securityLabel	Σ	0..*	CodingBinding	There are no (further) constraints on this element Element id Consent.provision.securityLabel Short description Security Labels that define affected resources Definition A security label, comprised of 0..* security label fields (Privacy tags), which define which resources are controlled by this exception. Comments If the consent specifies a security label of "R" then it applies to all resources that are labeled "R" or lower. E.g. for Confidentiality, it's a high water mark. For other kinds of security labels, subsumption logic applies. When the purpose of use tag is on the data, access request purpose of use shall not conflict. Data type Coding Binding Security Labels from the Healthcare Privacy and Security Classification System. All Security Labels (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
purpose	Σ	0..*	CodingBinding	There are no (further) constraints on this element Element id Consent.provision.purpose Short description Context of activities covered by this rule Definition The context of the activities a user is taking - why the user is accessing the data - that are controlled by this rule. Comments When the purpose of use tag is on the data, access request purpose of use shall not conflict. Data type Coding Binding What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels. v3.PurposeOfUse (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
class	Σ	0..*	CodingBinding	There are no (further) constraints on this element Element id Consent.provision.class Short description e.g. Resource Type, Profile, CDA, etc. Definition The class of information covered by this rule. The type can be a FHIR resource type, a profile on a type, or a CDA document, or some other type that indicates what sort of information the consent relates to. Comments Multiple types are or'ed together. The intention of the contentType element is that the codes refer to profiles or document types defined in a standard or an implementation guide somewhere. Data type Coding Binding The class (type) of information a consent rule covers. ConsentContentClass (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
code	Σ	0..*	CodeableConcept	There are no (further) constraints on this element Element id Consent.provision.code Short description e.g. LOINC or SNOMED CT code, etc. in the content Definition If this code is found in an instance, then the rule applies. Comments Typical use of this is a Document code with class = CDA. Data type CodeableConcept Binding If this code is found in an instance, then the exception applies. ConsentContentCodes (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
dataPeriod	Σ I	0..1	Period	There are no (further) constraints on this element Element id Consent.provision.dataPeriod Short description Timeframe for data controlled by this rule Definition Clinical or Operational Relevant period of time that bounds the data controlled by this rule. Comments This has a different sense to the Consent.period - that is when the consent agreement holds. This is the time period of the data that is controlled by the agreement. Data type Period Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` per-1: If present, start SHALL have a lower value than end `start.hasValue().not() or end.hasValue().not() or (start <= end)` Mappings rim: n/a v2: DR rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
data	Σ	0..*	BackboneElement	There are no (further) constraints on this element Element id Consent.provision.data Short description Data controlled by this rule Definition The resources controlled by this rule if specific resources are referenced. Meaning when missing all data Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: Role
id		0..1	string	There are no (further) constraints on this element Element id Consent.provision.data.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id Consent.provision.data.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id Consent.provision.data.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
meaning	Σ	1..1	codeBinding	There are no (further) constraints on this element Element id Consent.provision.data.meaning Short description instance \| related \| dependents \| authoredby Definition How the resource reference is interpreted when testing consent restrictions. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Binding How a resource reference is interpreted when testing consent restrictions. ConsentDataMeaning (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
reference	Σ I	1..1	Reference(Resource)	There are no (further) constraints on this element Element id Consent.provision.data.reference Short description The actual data reference Definition A reference to a specific resource that defines which resources are covered by this consent. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Resource) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
provision		0..*	see (provision)	There are no (further) constraints on this element Element id Consent.provision.provision Short description Nested Exception Rules Definition Rules which provide exceptions to the base rule or subrules.

Erläuterungen

Item	Erläuterung
extension.domainReference.domain	Verweis auf die zugehörige Domain (Studie oder Organisation) als ValueReference
extension.domainReference.status	Status des Domänenbezugs gemäß http://hl7.org/fhir/publication-status
status	Finalisierungsstatus des Consent
scope.coding	Bereich für den die Einwilligung erteilt wurde gemäß [http://terminology.hl7.org/CodeSystem/consentscope]. - adr: Willenserklärungen der Patienten für den Fall der Einwilligungsunfähigkeit (z.B. Patientenverfügung, Vorsorgevollmacht, Betreuungsverfügung) - research: Forschung (z.B. Teilnahme an klinischen Studien) - patient-privacy: Datenschutz/Datenverarbeitung - treatment: Behandlung (z.B. OP-Einwilligung)

category:consentCategory.coding	Consent-Kategorie gemäß https://www.hl7.org/fhir/valueset-consent-category.html, hier: gängiger Patient Consent (code=59284-0) bzw. im Fall der MII Einwilligung: Privacy policy acknowledgement Document (code=57016-8).
category:resultType.coding	Ergebnistyp gemäß ResultType. Wenn als Ergebnistyp document angegeben ist, muss die Art des (Quell-)Dokuments im Slice templateType ebenfalls angegeben werden.
category:templateType.coding	Kategorisierung gemäß TemplateType. Dient als informelles Element der Differenzierung zwischen Einwilligung, Widerruf, Widerspruch und Ablehnung.
patient	Referenz auf Patient, für den die Einwilligungserklärung gilt
dateTime	Zeitpunkt und Gültigkeitsbeginn der Einwilligung. Die hier vorhandene Angabe muss analog zur Angabe im entsprechenden QuestionnaireResponse sein und ist typischweise identisch mit dem Datum der Unterschrift des Patienten in der zugehörigen Provenance-Ressource (PROVENCANCE.signature.WHEN des Patienten). Hinweis: Beinhaltet die Consent-Ressource aggregierte Einwilligungsinformationen, sollte das Unterschriftsdatum des neuesten für den Patienten relevanten Dokuments (Einwilligung, Widerruf, Ablehnung oder Widerspruch) verwendet werden. Hinweis: Wenn ResultType=ConsentStatus, dann Zeitpunkt der Generierung der Consent-Ressource mit der Category `Consent-Status`.

organization	Referenz auf 1-n zugeordnete Organization-Ressourcen, z.B. um Gültigkeit der MII zu deklarieren.
source	Empfohlen, aber nicht verpflichtend: Referenz(en) auf die Grundlage, z.B. QuestionnaireResponse-Ressourcen und/oder Scans, aus der sich diese Consent-Ressource ergibt.
policy	Grundlage der Policies für die die betroffene Person eine Aussage getroffen hat (eingewilligt, nicht eingewilligt, etc.) und die durch diese Consent-Ressource für den angegebenen Zeitraum gelten. Für die MII ist gemäß Konzept der Task Force Consent Umsetzung die Angabe einer eindeutigen URI ausreichend.

Suchparameter

Für dieses Profil wird im Rahmen dieses Leitfadens der Suchparameter "domain" definiert. Insbesondere wird empfohlen, logische Referenzen (Reference by Identifier, im Suchparameter: modifier ":identifier") zu unterstützen.

Invocations

[base]/Consent?domain=[id]

Details

Resource	Code	Type	FhirPath
Consent	domain	reference	extension('http://fhir.de/ConsentManagement/StructureDefinition/DomainReference').extension('domain').valueReference

Beispiel:

GET [base]/Consent?domain:identifier=epa

findet alle Consent-Ressourcen, die einer Domain "epa" zugeordnet sind.

Weiterhin sollte der Standard-Suchparameter category unterstützt werden, so dass sowohl nach ResultTypes als auch nach TemplateTypes, aber auch nach der generischere ConsentCategory gesucht werden kann.

Beispiel 1:

GET [base]/Consent?category=http://fhir.de/ConsentManagement/CodeSystem/ResultType|document

findet alle Consent-Ressourcen vom Ergebnis-Typ "Dokument".

Beispiel 2:

GET [base]/Consent?category=http://fhir.de/ConsentManagement/CodeSystem/TemplateType|WITHDRAWAL

findet alle Consent-Ressourcen vom Typ "Widerruf".

Auch die Suche nach dem Patienten (Suchparameter patient) incl. chaining ist für einen sinnvollen Einsatz faktisch zwingend

Beispiel 3:

GET [base]/Consent?patient.identifier=XYZ

findet alle Consent-Ressourcen des Patienten mit Business Identifier "XYZ".

Die Suchparameter sollten beliebig verknüpfbar sein gemäß den Regeln, die im FHIR Standard vorgegeben sind.

Beispiel 4:

GET [base]/Consent?category=http://fhir.de/ConsentManagement/CodeSystem/ResultType|consent-status&domain:identifier=myProject&patient.identifier=XYZ

ermittelt den aggregierten Einwilligungsstand (result-type=consent-status) (in Form einer Consent-Ressource) für den Patienten XYZ in der Domain myProject

Beispiel 5:

GET [base]/Consent?category=http://fhir.de/ConsentManagement/CodeSystem/ResultType|policy&domain:identifier=myProject

liefert alle aktuell gültigen Policies in der Domain myProject. Jede Policy wird in einer separaten Consent-Ressource (category result-type=policy) ausgeleitet.

Erste Erfahrungen aus der Praxis zum bisherigen IG (Stand 2021)

Konzeptuell folgt die initiale Struktur der Consent-Ressource der DSGVO-Vorgabe zum Opt-In: es ist nur erlaubt, was explizit zu einem bestimmten Zeitpunkt (Zeitpunkt der Einwilligung) eingewilligt wurde. Dies wird über verschachtelte Provision-Elemente realisiert:

Dabei verbietet das übergeordnete Provision-Element (Level1-Provision) alles (Provision.Type=DENY), außer es ist in Form von untergeordneten Provision-Elementen (Level2-Provisions) explizit erlaubt. Daher wurde bislang empfohlen als untergeordnete Provisions nur Provision-Elemente mit Provision.Type=PERMIT zu verwenden.

Erste Erfahrungen aus der Praxis zeigen, dass der Verzicht auf untergeordnete Provision-Elemente vom Typ Provision.Type=DENY es erschwert:

Änderungen im Einwilligungsstatus eines Patienten durch aktualisierte Einwilligungen zu verfolgen (Business-Logik zum Vergleich früherer Consent-Ressourcen mit aktuellen Consent-Ressourcen erforderlich)
Vollständige Einwilligungsstände eines Patienten (die sich auf mehr als ein Consent.Source beziehen) auszuleiten
Widerrufe als Consent-Ressourcen abzubilden

Aus diesem Grund wurden in der vorliegenden Version des IG die Kardinalitäten überarbeitet und sollten nachfolgende Empfehlungen bei der Umsetzung von Consent-Ressourcen berücksichtigt werden.

Aus den unterschiedlichen Szenarien (Opt-In vs. Opt-Out) und Arten von Einwilligungsdokumenten (Einwilligung, Widerruf, Widerspruch, etc.) ergeben sich unterschiedliche strukturelle Abbildungen bezogen auf die resultierenden Consent-Ressourcen.

Der Domänenbezug der Consent-Ressource wurde so erweitert, dass dieser Aufschluss über den Einwilligungsansatz der Einwilligungsdomäne (Opt-In oder Opt-Out) gibt (vgl. ResearchStudy.category).

Szenario	Bezug	TemplateType	ResultType	Consent enthält aggregierte Informationen?	Kardinalität Provenance. entity	Level1 Provision.Type	Level2 Provision.Type(s)
Opt-In	Einwilligung (Typ Opt-In)	System: http://loinc.org Code: 59284-0	document	nein	1..1	DENY	PERMIT, DENY
	Widerruf (vollständig)	System: http://fhir.de/ConsentManagement/CodeSystem/TemplateType Code: WITHDRAWAL	document	Nein	0..1	DENY	DENY
	Widerruf (teilweise)	System: http://fhir.de/ConsentManagement/CodeSystem/TemplateType Code: WITHDRAWAL	document	Nein	0..1	DENY	PERMIT, DENY
	Ablehnung	System: http://fhir.de/ConsentManagement/CodeSystem/TemplateType Code: REFUSAL	document	Nein	0..1	DENY	DENY
	Einwilligungsstand (Typ Opt-In)	n.a.	consent-status	Ja	0..*	DENY	PERMIT, DENY
Opt-Out	Einwilligung (Typ Opt-Out)	System: http://fhir.de/ConsentManagement/CodeSystem/TemplateType Code: CONSENT-OPT-OUT	document	Nein	0..1	PERMIT	PERMIT
	Widerspruch (vollständig)	System: http://fhir.de/ConsentManagement/CodeSystem/TemplateType Code: OBJECTION	document	Nein	0..1	DENY	PERMIT, DENY
	Widerspruch (teilweise)	System: http://fhir.de/ConsentManagement/CodeSystem/TemplateType Code: OBJECTION	document	Nein	0..1	DENY	PERMIT, DENY
	Einwilligungsstand (Typ Opt-Out)	n.a.	consent-status	Ja	0..*	DENY	PERMIT, DENY

Besonderer Hinweis: Es muss in allen Konstellationen sichergestellt werden, dass die semantische Bedeutung vom ausgefüllten Dokument bis hin zur maschinenlesbaren Interpretation korrekt in der Consent-Ressource abgebildet wird (z.B. im Fall von Widerrufe, Widersprüchen und Ablehnung).

Opt-In-Ansatz

Das Opt-In-Prinzip legt zugrunde, dass alles untersagt ist, was nicht explizit von der betroffenen Person erlaubt wurde. Eine Teilnahme an einem entsprechenden Vorhaben erfolgt per Einwilligung (Typ: Opt-In) und kann durch einen (formlosen) Widerruf aufgehoben werden. Diesem Ansatz folgt beispielsweise der Broad Consent der Medizininformatik-Initiative.

Der Ansatz spiegelt sich in der Struktur der Consent-Ressource wider. Das übergeordnete Provision-Element (Level1-Provision) verbietet im Kontext des konkreten Forschungsvorhabens zunächst alles (Provision.Type=DENY). Untergeordnete Provision-Elemente (Level2-Provisions) können sowohl Provision-Elemente vom Provision.Type=PERMIT als auch Provision-Elemente vom Provision.Type=DENY enthalten.

Das DENY im übergeordneten Provision-Element (Level1) bewirkt, dass, auch wenn eine abgelehnte Einwilligungspolicy auf Level2 zwar nicht explizit erwähnt wird, diese implizit jedoch gleichzeitig gilt. Das Fehlen einer Erlaubnis führt also nicht dazu, dass eine Erlaubnis besteht. Dieses erschwert jedoch das ermitteln von Unterschieden (DIFFs) bezogen auf mehre Abfragezeitpunkte. Insofern ist das explizite Mitführen von abgelehnten Policies in Form von Provisions vom Provision.Type=DENY ratsam, auch wenn nicht sichergestellt werden kann, dass alle Drittsysteme diese auch auswerten.

Die Consent-Ressourcen sind im Opt-In-Szenario strukturell identisch. Dies gilt sowohl für Consent-Ressourcen, die auf Einwilligungsdokumenten basieren, aber auch für solche, die auf Widerrufen oder Ablehnungen beruhen.

Einwilligung (Typ Opt-In)

Die Level1-Provision verbietet alles (Provision.Type=DENY). Level2-Provisions sind verpflichtend und können sowohl Provision-Elemente mit Provision.Type=PERMIT als Provision-Elemente mit Provision.Type=DENY enthalten.

Widerruf (vollständig)

Ein Patient hat explizit seinen vollständigen Widerruf zu mehreren Sachverhalten im Kontext eines Forschungsvorhabens erteilt. Aufgrund des potentiell formlosen Charakters eines Widerrufs kann ein Verweis auf das source-Element im Einzelfall entfallen, sollte aber gesetzt sein, sofern ein entsprechendes Medium existiert. Da die Gültigkeit eines Widerrufs i.d.R. nicht abläuft, ist bei der Gültigkeitsangabe ausschließlich period.start anzugeben.

Die Level1-Provision verbietet im Kontext des konkreten Forschungsvorhabens alles (Provision.Type=DENY). Da die Gültigkeit eines Widerrufs i.d.R. nicht abläuft ist bei der Gültigkeitsangabe ausschließlich period.start anzugeben.

Widerruf (teilweise)

Ein Patient hat explizit seinen Widerruf zu einem oder mehreren Sachverhalten im Kontext eines Forschungsvorhabens erteilt. Je nach Ausprägung können Bestandteile einer geltenden Einwilligung weiterhin Gültigkeit haben. Aufgrund des potentiell formlosen Charakters eines Teil-Widerrufs kann ein Verweis auf das source-Element im Einzelfall entfallen, sollte aber gesetzt sein, sofern ein entsprechendes Medium existiert.

Die Struktur der Consent-Ressource vom Typ 'Widerruf (teilweise)' unterscheidet sich vom vollständigen Widerruf. Die Level1-Provision verbietet im Kontext des konkreten Forschungsvorhabens alles (Provision.Type=DENY). Da die Gültigkeit eines Widerrufs i.d.R. nicht abläuft ist bei der Gültigkeitsangabe ausschließlich period.start anzugeben.

Level2-Provisions können zur Konkretisierung von Aussagen (Provision.Type=DENY und Provision.Type=PERMIT) verwendet werden, um weiterhin gültige Einwilligungspolicies, die nicht vom Teilwiderruf betroffen sind, auszuleiten. Diese werden von Drittsystemen möglicherweise jedoch nicht ausgewertet. Entsprechende Gültigkeitsangaben (Provision.period)sind zu verwenden.

Ablehnung

Ein Patient hat explizit seine Ablehnung zu einem oder mehreren Sachverhalten im Kontext eines Forschungsvorhabens erteilt. Aufgrund des potentiell formlosen Charakters einer Ablehnung kann ein Verweis auf das source-Element im Einzelfall entfallen, sollte aber gesetzt sein, sofern ein entsprechendes Medium existiert.

Die Struktur der Consent-Ressource vom Typ 'Ablehnung' verhält sich analog zum Typ 'Widerruf (vollständig)'.

Aggregierter Einwilligungsstand (Typ: Opt-In)

Aus der Aggregation von mehreren Einwilligungsdokumenten und evtl. vorhandenen Widerrufen/Ablehnungen eines Patienten im Kontext eines Forschungsvorhabens ergibt sich eine errechneter Einwilligungsstand. Daher ist ein Verweis auf ein oder mehrere Quelldokumente verbindlich, sofern vorhanden. Dabei ist Provenance.entity zu verwenden. Details siehe Beispiel des Provenance-Profils.

Die Level1-Provision verbietet im Kontext des konkreten Forschungsvorhabens alles (Provision.Type=DENY) und der Zeitraum der Gültigkeit der Level1-Provision ergibt sich aus dem Beginn der Gültigkeit des ältesten Dokuments (period.start) und dem Ende der Gültigkeit des neuesten Dokuments (period.end).

Level2-Provisions sind verpflichtend und können sowohl Provision-Elemente mit Provision.Type=PERMIT als auch Provision-Elemente mit Provision.Type=DENY enthalten. Die Gültigkeitszeiträume können voneinander abweichen.

Die potentiell multiplen Quell-Dokumente (QuestionnaireResponse, DocumentReference), die in die Ermittlung des aggregierten Einwilligungsstandes eingeflossen sind, können mittels Provenance.entity referenziert werden, wobei entity.what die Referenz auf das Dokument darstellt und entity.role = 'source' gesetzt wird.

Opt-Out-Ansatz

Das Opt-Out-Prinzip invertiert das bislang betrachtete Opt-In-Prinzip: es gilt als erlaubt, was nicht explizit untersagt wurde. Eine Teilnahme an einem entsprechenden Vorhaben kann durch einen sogenannten Widerspruch aufgehoben werden. Dies ist beispielsweise für die Umsetzung der geplanten elektronische Patientenakte (ePA) und die Gewährleistung der nötigen Freiwilligkeit relevant.

Einwilligung (Typ Opt-Out)

Da ein Patient im Fall von Opt-Out nicht explizit eingewilligt hat, existiert keine zugeordnete QuestionnaireResponse-Ressource. Insofern kann der Verweis auf das source-Element entfallen.

Die Anlage einer Patientenspezifischen Consent-Ressource vom Typ „Opt-Out-Consent“ im verwaltenden System sollte erfolgen, sobald der Patient im System bekannt gemacht wird, d.h. sobald entsprechende Informationen zum Patientenbezug (Pseudonym, Fallnummer, etc.) und Vorhabenbezug (Forschungsvorhaben, Kontext) im System vorhanden sind. Die Erzeugung einer Patientenspezifischen Consent-Ressource vom Typ „Opt-Out-Consent“ im verwaltenden System sollte jedoch spätestens zum Zeitpunkt der Abfrage von Consent-Ressourcen (Echtzeit-Generierung).

Die Level1-Provision erlaubt im Kontext des konkreten Forschungsvorhabens alles (Provision.Type=PERMIT). Level2-Provisions dürfen vorhanden sein, sofern explizite PERMITs zur Darstellung gültiger Einwilligungspolicies bekannt sind. Diese Level2-Provisions müssen verbindlich über einen entsprechenden Gültigkeitsbeginn je Einwilligungspolicies (provision.period.start) verfügen.

Widerspruch (vollständig)

Ein Patient hat explizit seinen Widerspruch zu einem oder mehreren Sachverhalten im Kontext einer Anwendungsdomäne erteilt. Aufgrund des potentiell formlosen Charakters eines Widerspruchs kann ein Verweis auf das source-Element im Einzelfall entfallen, sollte aber gesetzt sein, sofern ein entsprechendes Medium existiert.

Die Level1-Provision verbietet im Kontext des konkreten Forschungsvorhabens alles (Provision.Type=DENY). Da die Gültigkeit eines Widerspruchs i.d.R. nicht abläuft muss bei der Gültigkeitsangabe ausschließlich period.start angegeben werden.

Level2-Provisions zur Konkretisierung von Aussagen (Provision.Type=DENY) sind möglich, werden von Drittsystemen möglicherweise jedoch nicht ausgewertet. Dies ist insbesondere dann sinnvoll, wenn Dokumente in Form von Consent-Ressourcen ausgeleitet werden sollen mit anschließender Auswertung in einem (IHE) Policy Decision Point. Level2-Provisions müssen verbindlich über einen entsprechenden Gültigkeitsbeginn je Einwilligungspolicies (provision.period.start) verfügen.

Widerspruch (teilweise)

Ein Patient hat explizit seinen Widerspruch zu einem oder mehreren Sachverhalten im Kontext eines Forschungsvorhabens erteilt. Je nach Ausprägung können Bestandteile einer geltenden Einwilligung (Typ: Opt-Out) weiterhin Gültigkeit haben, z.B. wenn der Widerspruch nur bezogen auf ausgewählte Datenkategorien innerhalb der elektronischen Patientenakte gelten soll. Aufgrund des potentiell formlosen Charakters eines Teil-Widerspruchs kann ein Verweis auf das source-Element im Einzelfall entfallen, sollte aber gesetzt sein, sofern ein entsprechendes Medium existiert.

Die Struktur der Consent-Ressource vom Typ 'Widerspruch (teilweise)' unterscheidet sich vom vollständigen Widerspruch. Die Level1-Provision verbietet im Kontext des konkreten Forschungsvorhabens alles (Provision.Type=DENY). Da die Gültigkeit eines Widerspruchs i.d.R. nicht abläuft muss bei der Gültigkeitsangabe ausschließlich period.start angegeben werden.

Level2-Provisions können zur Konkretisierung von Aussagen (Typen: DENY, PERMIT) verwendet werden, um weiterhin gültige Einwilligungspolicies, die nicht vom Teilwiderspruch betroffen sind, auszuleiten. Diese werden von Drittsystemen möglicherweise jedoch nicht ausgewertet. Entsprechende Gültigkeitsangaben (Provision.period) sind zu verwenden.

Aggregierter Einwilligungsstand (Typ: Opt-Out)

Aus evtl. vorhandenen Widersprüchen eines Patienten im Kontext eines Forschungsvorhabens ergibt sich ein errechneter Einwilligungsstand (sozusagen eine Zusammenfassung der widersprochenen Sachverhalte). Insofern orientiert sich die resultierende Consent-Ressource grundlegend an der Consent-Struktur für 'Widerspruch (teilweise)' und 'Aggregierter Einwilligungsstand (Typ: Opt-In)'. Es können mehrere Quell-Elemente (mittels Provenance) je nach Vorhandensein referenziert werden. Besonderes Augenmerk ist auf Gültigkeitsangaben zu legen.

Die Level1-Provision verbietet im Kontext des konkreten Forschungsvorhabens alles (Provision.Type=DENY). Da die Gültigkeit eines Widerspruchs i.d.R. nicht abläuft, muss bei der Gültigkeitsangabe ausschließlich period.start (bezogen auf den ältesten gültigen Widerspruch) angegeben werden.

Level2-Provisions sind zur Konkretisierung von Aussagen (Typen: DENY, PERMIT) anzugeben, um zulässige und unzulässige Einwilligungspolicies klar differenziert ausleiten zu können. Entsprechende Gültigkeitsangaben (Provision.period) sind jeweils zu verwenden und können sich prinzipbedingt unterscheiden.

Beispiele

Beispiel 1: Consent mit Provisions entsprechend ValueSet der Medizininformatik-Initiative

<Consent xmlns="http://hl7.org/fhir">
    <id value="b1d3ed1a-597f-40dc-9270-9c5da9d4c631" />
    <meta>
        <lastUpdated value="2020-12-11T09:39:07+00:00" />
        <profile value="http://fhir.de/ConsentManagement/StructureDefinition/Consent" />
    </meta>
    <!--  Verweis auf die zugehörige Domain (hier: Studie)  -->
    <extension url="http://fhir.de/ConsentManagement/StructureDefinition/DomainReference">
        <extension url="domain">
            <valueReference>
                <reference value="ResearchStudy/d7a65ce8-2810-401a-b0db-70782a7b19a6" />
            </valueReference>
        </extension>
        <extension url="status">
            <valueCoding>
                <system value="http://hl7.org/fhir/publication-status" />
                <code value="active" />
            </valueCoding>
        </extension>
    </extension>
    <!--  Finalisierungsstatus  -->
    <status value="active" />
    <!--  Einwilligung zur Verwendung, hier: in der Forschung  -->
    <scope>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/consentscope" />
            <code value="research" />
        </coding>
    </scope>
    <!--  allgemeine Consent-Kategorie, hier: Einwilligung  -->
    <category>
        <coding>
            <system value="http://loinc.org" />
            <code value="59284-0" />
        </coding>
    </category>
    <!--  Consent-Kategorie resultType, hier: Dokument  -->
    <category>
        <coding>
            <system value="http://fhir.de/ConsentManagement/CodeSystem/ResultType" />
            <code value="document" />
        </coding>
    </category>
    <!--  Consent-Kategorie bezogen auf das ValueSet 'ConsentManagementTemplateType', hier: Einwilligung  -->
    <category>
        <coding>
            <system value="http://fhir.de/ConsentManagement/CodeSystem/TemplateType" />
            <code value="CONSENT-OPT-IN" />
        </coding>
    </category>
    <!--  Patient, für den die Einwilligungserklärung gilt  -->
    <patient>
        <reference value="Patient/9b4a702d-162c-428a-8c5d-8b98af21b693" />
    </patient>
    <!--  Zeitpunkt der Einwilligung  -->
    <dateTime value="2020-09-01" />
    <organization>
        <!--  hier kann bei Bedarf auch auf beliebige Organization-Ressourcen referenziert werden  -->
        <display value="Klinikum Musterstadt" />
    </organization>
    <!--  Verweis auf die Questionnaire-Response, aus der sich dieser Consent ergibt  -->
    <sourceReference>
        <reference value="QuestionnaireResponse/02eac854-6a2e-48f9-88d7-edd04faff81c" />
    </sourceReference>
    <!--  durch diesen Consent geltende Policy/Policies bzw Module -->
    <policy>
        <!--  hier z.B. MII Broad Consent  -->
        <uri value="https://www.medizininformatik-initiative.de/sites/default/files/2020-04/MII_AG-Consent_Einheitlicher-Mustertext_v1.6d.pdf" />
    </policy>
    <!--  XacML-Repräsentation  -->
    <policyRule>
        <extension url="http://fhir.de/ConsentManagement/StructureDefinition/Xacml">
            <valueBase64Binary value="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" />
        </extension>
        <text value="siehe eingebettetes XACML" />
    </policyRule>
    <!--  In diesem Beispiel repräsentiert jede Provision eine Frage/Antwort bzw. Teilaussage einer Frage/Antwort in der Einwilligungserklärung eines Patienten.  -->
    <provision>
        <!--  per default ist alles verweigert. was nicht in den Unterelementen erlaubt ist  -->
        <type value="deny" />
        <!--  längster Zeitraum der Gültigkeit  -->
        <period>
            <start value="2020-09-01" />
            <end value="2050-08-31" />
        </period>
        <provision>
            <!--  ergibt sich aus der Antwort "PATDAT_erheben_speichern_nutzen=gültig" (Teil 1)  -->
            <type value="permit" />
            <!--  Medizinische Daten erheben: 5 Jahre gültig  -->
            <period>
                <start value="2020-09-01" />
                <end value="2025-08-31" />
            </period>
            <code>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.6" />
                    <display value="MDAT_erheben" />
                </coding>
            </code>
        </provision>
        <provision>
            <!--  ergibt sich aus der Antwort "PATDAT_erheben_speichern_nutzen=gültig" (Teil 2)  -->
            <type value="permit" />
            <!--  Medizinische Daten speichern: 30 Jahre gültig  -->
            <period>
                <start value="2020-09-01" />
                <end value="2050-08-31" />
            </period>
            <code>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.7" />
                    <display value="MDAT_speichern_verarbeiten" />
                </coding>
            </code>
        </provision>
        <provision>
            <!--  ergibt sich aus der Antwort "PATDAT_erheben_speichern_nutzen=gültig" (Teil 3)  -->
            <type value="permit" />
            <!--  Medizinische Daten nutzen: 30 Jahre gültig  -->
            <period>
                <start value="2020-09-01" />
                <end value="2050-08-31" />
            </period>
            <code>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.8" />
                    <display value="MDAT_wissenschaftlich_nutzen_EU_DSGVO_NIVEAU" />
                </coding>
            </code>
        </provision>
        <provision>
            <!--  ergibt sich aus der Antwort "BIOMAT_gewinnen_lagern_nutzen=ungültig" (Teil 1)  -->
            <type value="deny" />
            <!--  Biomaterial gewinnen: unbegrenzt ungültig, die Gültigkeitszeit ergibt sich aus Provision Level 1   -->
            <code>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.19" />
                    <display value="BIOMAT_erheben" />
                </coding>
            </code>
        </provision>
        <provision>
            <!--  ergibt sich aus der Antwort "BIOMAT_gewinnen_lagern_nutzen=ungültig" (Teil 2)  -->
            <type value="deny" />
            <!--  Biomaterial lagern: unbegrenzt ungültig, die Gültigkeitszeit ergibt sich aus Provision Level 1  -->
            <code>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.20" />
                    <display value="BIOMAT_lagern_verarbeiten" />
                </coding>
            </code>
        </provision>
        <provision>
            <!--  ergibt sich aus der Antwort "BIOMAT_gewinnen_lagern_nutzen=ungültig" (Teil 3)  -->
            <type value="deny" />
            <!--  Biomaterial nutzen: unbegrenzt ungültig, die Gültigkeitszeit ergibt sich aus Provision Level 1  -->
            <code>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.22" />
                    <display value="BIOMAT_wissenschaftlich_nutzen_EU_DSGVO_NIVEAU" />
                </coding>
            </code>
        </provision>
    </provision>
</Consent>

Beispiel 2: Consent mit Provisions charakterisiert durch Consent Content (code) und Consent Action (action) (exemplarische Codierungen)

<Consent xmlns="http://hl7.org/fhir">
    <id value="df4e3ba1-f5d0-4655-986f-7b5fbec95224" />
    <meta>
        <lastUpdated value="2022-07-20T09:00:00+02:00" />
        <profile value="http://fhir.de/ConsentManagement/StructureDefinition/Consent" />
    </meta>
    <!--  Verweis auf die zugehörige Domain (hier: Studie)  -->
    <extension url="http://fhir.de/ConsentManagement/StructureDefinition/DomainReference">
        <extension url="domain">
            <valueReference>
                <reference value="ResearchStudy/d7a65ce8-2810-401a-b0db-70782a7b19a6" />
            </valueReference>
        </extension>
        <extension url="status">
            <valueCoding>
                <system value="http://hl7.org/fhir/publication-status" />
                <code value="active" />
            </valueCoding>
        </extension>
    </extension>
    <!--  Finalisierungsstatus  -->
    <status value="active" />
    <!--  Einwilligung zur Verwendung, hier: in der Forschung  -->
    <scope>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/consentscope" />
            <code value="research" />
        </coding>
    </scope>
    <!--  allgemeine Consent-Kategorie, hier: Einwilligung  -->
    <category>
        <coding>
            <system value="http://loinc.org" />
            <code value="59284-0" />
        </coding>
    </category>
    <!--  Consent-Kategorie resultType, hier: Dokument  -->
    <category>
        <coding>
            <system value="http://fhir.de/ConsentManagement/CodeSystem/ResultType" />
            <code value="document" />
        </coding>
    </category>
    <!--  Consent-Kategorie bezogen auf das ValueSet 'ConsentManagementTemplateType', hier: Einwilligung  -->
    <category>
        <coding>
            <system value="http://fhir.de/ConsentManagement/CodeSystem/TemplateType" />
            <code value="CONSENT-OPT-IN" />
        </coding>
    </category>
    <!--  Patient, für den die Einwilligungserklärung gilt  -->
    <patient>
        <reference value="Patient/9b4a702d-162c-428a-8c5d-8b98af21b693" />
    </patient>
    <!--  Zeitpunkt der Einwilligung  -->
    <dateTime value="2020-09-01" />
    <organization>
        <!--  hier kann bei Bedarf auch auf beliebige Organization-Ressourcen referenziert werden  -->
        <display value="Klinikum Musterstadt" />
    </organization>
    <!--  Verweis auf die Questionnaire-Response, aus der sich dieser Consent ergibt  -->
    <sourceReference>
        <reference value="QuestionnaireResponse/02eac854-6a2e-48f9-88d7-edd04faff81c" />
    </sourceReference>
    <!--  durch diesen Consent geltende Policy/Policies bzw Module -->
    <policy>
        <!--  hier z.B. MII Broad Consent  -->
        <uri value="https://www.medizininformatik-initiative.de/sites/default/files/2020-04/MII_AG-Consent_Einheitlicher-Mustertext_v1.6d.pdf" />
    </policy>
    <!--  XacML-Repräsentation  -->
    <policyRule>
        <extension url="http://fhir.de/ConsentManagement/StructureDefinition/Xacml">
            <valueBase64Binary value="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" />
        </extension>
        <text value="siehe eingebettetes XACML" />
    </policyRule>
    <!--  In diesem Beispiel repräsentiert jede Provision eine Frage/Antwort bzw. Teilaussage einer Frage/Antwort in der Einwilligungserklärung eines Patienten.  -->
    <provision>
        <!--  per default ist alles verweigert. was nicht in den Unterelementen erlaubt ist  -->
        <type value="deny" />
        <!--  längster Zeitraum der Gültigkeit  -->
        <period>
            <start value="2020-09-01" />
            <end value="2050-08-31" />
        </period>
        <provision>
            <type value="permit" />
            <period>
                <start value="2020-09-01" />
                <end value="2025-08-31" />
            </period>
            <action>
                <coding>
                    <!--  Das verwendete Codesystem dient lediglich der Veranschaulichung und ist nirgends definiert  -->
                    <system value="http://beispiel.fhir.de/CodeSystem/ConsentAction" />
                    <code value="erheben" />
                    <display value="erheben" />
                </coding>
            </action>
            <code>
                <coding>
                    <!--  Das verwendete Codesystem dient lediglich der Veranschaulichung und ist nirgends definiert  -->
                    <system value="http://beispiel.fhir.de/CodeSystem/ConsentContent" />
                    <code value="MDAT" />
                    <display value="Medizinische Daten" />
                </coding>
            </code>
        </provision>
        <provision>
            <!--  ergibt sich aus der Antwort "PATDAT_erheben_speichern_nutzen=gültig" (Teil 2)  -->
            <type value="permit" />
            <!--  Medizinische Daten speichern: 30 Jahre gültig  -->
            <period>
                <start value="2020-09-01" />
                <end value="2050-08-31" />
            </period>
            <action>
                <coding>
                    <!--  Das verwendete Codesystem dient lediglich der Veranschaulichung und ist nirgends definiert  -->
                    <system value="http://beispiel.fhir.de/CodeSystem/ConsentAction" />
                    <code value="speichern_verarbeiten" />
                    <display value="speichern und verarbeiten" />
                </coding>
            </action>
            <code>
                <coding>
                    <!--  Das verwendete Codesystem dient lediglich der Veranschaulichung und ist nirgends definiert  -->
                    <system value="http://beispiel.fhir.de/CodeSystem/ConsentContent" />
                    <code value="MDAT" />
                    <display value="Medizinische Daten" />
                </coding>
            </code>
        </provision>
        <provision>
            <!--  ergibt sich aus der Antwort "PATDAT_erheben_speichern_nutzen=gültig" (Teil 3)  -->
            <type value="permit" />
            <!--  Medizinische Daten nutzen: 30 Jahre gültig  -->
            <period>
                <start value="2020-09-01" />
                <end value="2050-08-31" />
            </period>
            <action>
                <coding>
                    <!--  Das verwendete Codesystem dient lediglich der Veranschaulichung und ist nirgends definiert  -->
                    <system value="http://beispiel.fhir.de/CodeSystem/ConsentAction" />
                    <code value="wissenschaftlich_nutzen" />
                    <display value="wissenschaftlich nutzen auf EU-DSGVO-Niveau" />
                </coding>
            </action>
            <code>
                <coding>
                    <!--  Das verwendete Codesystem dient lediglich der Veranschaulichung und ist nirgends definiert  -->
                    <system value="http://beispiel.fhir.de/CodeSystem/ConsentContent" />
                    <code value="MDAT" />
                    <display value="Medizinische Daten" />
                </coding>
            </code>
        </provision>
        <provision>
            <!--  ergibt sich aus der Antwort "BIOMAT_gewinnen_lagern_nutzen=ungültig" (Teil 1)  -->
            <type value="deny" />
            <!--  Biomaterial gewinnen: unbegrenzt ungültig, die Gültigkeitszeit ergibt sich aus Provision Level 1   -->
            <action>
                <coding>
                    <!--  Das verwendete Codesystem dient lediglich der Veranschaulichung und ist nirgends definiert  -->
                    <system value="http://beispiel.fhir.de/CodeSystem/ConsentAction" />
                    <code value="erheben" />
                    <display value="erheben" />
                </coding>
            </action>
            <code>
                <coding>
                    <!--  Das verwendete Codesystem dient lediglich der Veranschaulichung und ist nirgends definiert  -->
                    <system value="http://beispiel.fhir.de/CodeSystem/ConsentContent" />
                    <code value="BIOMAT" />
                    <display value="Biomaterial" />
                </coding>
            </code>
        </provision>
        <provision>
            <!--  ergibt sich aus der Antwort "BIOMAT_gewinnen_lagern_nutzen=ungültig" (Teil 2)  -->
            <type value="deny" />
            <!--  Biomaterial lagern: unbegrenzt ungültig, die Gültigkeitszeit ergibt sich aus Provision Level 1  -->
            <action>
                <coding>
                    <!--  Das verwendete Codesystem dient lediglich der Veranschaulichung und ist nirgends definiert  -->
                    <system value="http://beispiel.fhir.de/CodeSystem/ConsentAction" />
                    <code value="lagern_verarbeiten" />
                    <display value="lagern und verarbeiten" />
                </coding>
            </action>
            <code>
                <coding>
                    <!--  Das verwendete Codesystem dient lediglich der Veranschaulichung und ist nirgends definiert  -->
                    <system value="http://beispiel.fhir.de/CodeSystem/ConsentContent" />
                    <code value="BIOMAT" />
                    <display value="Biomaterial" />
                </coding>
            </code>
        </provision>
        <provision>
            <!--  ergibt sich aus der Antwort "BIOMAT_gewinnen_lagern_nutzen=ungültig" (Teil 3)  -->
            <type value="deny" />
            <!--  Biomaterial nutzen: unbegrenzt ungültig, die Gültigkeitszeit ergibt sich aus Provision Level 1  -->
            <action>
                <coding>
                    <!--  Das verwendete Codesystem dient lediglich der Veranschaulichung und ist nirgends definiert  -->
                    <system value="http://beispiel.fhir.de/CodeSystem/ConsentAction" />
                    <code value="wissenschaftlich_nutzen" />
                    <display value="wissenschaftlich nutzen auf EU-DSGVO-Niveau" />
                </coding>
            </action>
            <code>
                <coding>
                    <!--  Das verwendete Codesystem dient lediglich der Veranschaulichung und ist nirgends definiert  -->
                    <system value="http://beispiel.fhir.de/CodeSystem/ConsentContent" />
                    <code value="BIOMAT" />
                    <display value="Biomaterial" />
                </coding>
            </code>
        </provision>
    </provision>
</Consent>

Beispiel 3: Consent mit Provisions zur Übermittlung eines Einwilligungsstandes

<Consent xmlns="http://hl7.org/fhir">
    <id value="a1480fd8-5a07-439e-9635-16e81b71447a" />
    <meta>
        <lastUpdated value="2024-01-15T15:04:08.701+01:00" />
        <profile value="http://fhir.de/ConsentManagement/StructureDefinition/Consent" />
    </meta>
    <extension url="http://fhir.de/ConsentManagement/StructureDefinition/DomainReference">
        <extension url="domain">
            <valueReference>
                <reference value="ResearchStudy/1bf8568b-bfa4-49f4-8a3a-51024974012b" />
            </valueReference>
        </extension>
        <extension url="status">
            <valueCoding>
                <system value="http://hl7.org/fhir/publication-status" />
                <code value="active" />
            </valueCoding>
        </extension>
    </extension>
    <status value="active" />
    <scope>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/consentscope" />
            <code value="research" />
        </coding>
    </scope>
    <category>
        <coding>
            <system value="http://loinc.org" />
            <code value="57016-8" />
        </coding>
    </category>
    <category>
        <coding>
            <system value="http://fhir.de/ConsentManagement/CodeSystem/ResultType" />
            <code value="consent-status" />
        </coding>
    </category>
    <patient>
        <reference value="Patient/6ae55815-07e8-4cbf-a900-5bccca739a7a" />
        <display value="studyPSN dic_810MT" />
    </patient>
    <dateTime value="2024-01-15T00:00:00+01:00" />
    <organization>
        <display value="MII" />
    </organization>
    <policy>
        <uri value="urn:oid:2.16.840.1.113883.3.1937.777.24.2.184" />
    </policy>
    <provision>
        <type value="deny" />
        <period>
            <start value="2024-01-01T00:00:00+01:00" />
            <end value="2029-01-01T00:00:00+01:00" />
        </period>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-01-15T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="IDAT_erheben" />
                    <display value="Erfassung neuer identifizierender Daten (IDAT)" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.2" />
                    <display value="IDAT erheben" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-01-15T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="MDAT_erheben" />
                    <display value="Erfassung medizinischer Daten (MDAT)" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.6" />
                    <display value="MDAT erheben" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="permit" />
            <period>
                <start value="2024-01-01T00:00:00+01:00" />
                <end value="2054-01-01T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="IDAT_bereitstellen_EU_DSGVO_konform" />
                    <display value="Herausgabe identifizierender Daten (IDAT) an unabh&#228;ngige Treuhandstelle zur weiteren Verarbeitung" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.5" />
                    <display value="IDAT bereitstellen EU DSGVO NIVEAU" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-01-15T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="Rekontaktierung_Ergebnisse_erheblicher_Bedeutung" />
                    <display value="Rekontaktierung des Betroffenen bei Ergebnissen von erheblicher Bedeutung" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.37" />
                    <display value="Rekontaktierung Ergebnisse erheblicher Bedeutung" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="permit" />
            <period>
                <start value="2024-01-01T00:00:00+01:00" />
                <end value="2054-01-01T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="MDAT_zusammenfuehren_Dritte" />
                    <display value="Zusammenf&#252;hrung medizinischer Daten (MDAT) mit Dritten Forschungspartnern, sofern dort eine Einwilligung vorliegt" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.9" />
                    <display value="MDAT zusammenfuehren Dritte" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="permit" />
            <period>
                <start value="2024-01-01T00:00:00+01:00" />
                <end value="2054-01-01T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="MDAT_speichern_verarbeiten" />
                    <display value="Speicherung und Verarbeitung von medizinischen codierten Daten zu Zwecken med. Forschung innerhalb der verantwortlichen Stelle (MDAT)" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.7" />
                    <display value="MDAT speichern, verarbeiten" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-01-15T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="Rekontaktierung_Zusatzbefund" />
                    <display value="Rekontaktierung bez&#252;glich Zusatzbefund im Rahmen der am Standort daf&#252;r entwickelten Prozesse und der im Nutzungsantrag angegebenen Bedingungen" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.31" />
                    <display value="Rekontaktierung Zusatzbefund" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="permit" />
            <period>
                <start value="2024-01-01T00:00:00+01:00" />
                <end value="2054-01-01T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="IDAT_speichern_verarbeiten" />
                    <display value="Speicherung und Verarbeitung identifizierender Daten (IDAT) zu Zwecken med. Forschung in der verantwortlichen Stelle" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.3" />
                    <display value="IDAT speichern, verarbeiten" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-01-15T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_5J_pro_speichern_verarbeiten" />
                    <display value="Prospektive Krankenkassendaten (KKDAT) aus f&#252;nf Jahren ab Einwilligung speichern und codiert verarbeiten zu Zwecken der med. Forschung in der verantwortlichen Stelle" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.16" />
                    <display value="KKDAT 5J prospektiv speichern verarbeiten" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-01-15T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="Rekontaktierung_Verknuepfung_Datenbanken" />
                    <display value="Rekontaktierung zur Verkn&#252;pfung von Patientendaten mit Daten anderer Datenbanken" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.27" />
                    <display value="Rekontaktierung Verkn&#252;pfung Datenbanken" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-01-15T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_KVNR_5J_pro_uebertragen" />
                    <display value="Erlaubnis zur prospektiven &#220;bermittlung der KVNr., MII-Pseudonym und Zeitraum Daten&#252;bermittlung (von: Datum Unterschrift; bis: max. 5 Kalenderjahre nach Unterschrift) an zust&#228;ndige Stelle" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.39" />
                    <display value="KKDAT 5J prospektiv uebertragen KVNR" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-01-15T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_KVNR_5J_retro_uebertragen" />
                    <display value="Erlaubnis zur retrospektiven &#220;bermittlung der KVNr., MII-Pseudonym und Zeitraum Daten&#252;bermittlung (von:5 Jahre vor Datum Unterschrift; bis: Datum Unterschrift) an zust&#228;ndige Stelle" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.38" />
                    <display value="KKDAT 5J retrospektiv uebertragen KVNR" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="permit" />
            <period>
                <start value="2024-01-01T00:00:00+01:00" />
                <end value="2054-01-01T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="MDAT_wissenschaftlich_nutzen_EU_DSGVO_konform" />
                    <display value="Bereitstellung umcodierter medizinischer Daten (MDAT) f&#252;r wissenschaftliche Nutzung zu Zwecken med. Forschung an externe Forscher" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.8" />
                    <display value="MDAT wissenschaftlich nutzen EU DSGVO NIVEAU" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-01-15T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_5J_pro_uebertragen" />
                    <display value="Prospektive Krankenkassendaten (KKDAT) f&#252;r f&#252;nf Kalenderjahre nach Datum Unterschrift &#252;bertragen" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.15" />
                    <display value="KKDAT 5J prospektiv uebertragen" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-01-15T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="Rekontaktierung_weitere_Erhebung" />
                    <display value="Rekontaktierung bez&#252;glich Erhebung zus&#228;tzlicher Daten" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.28" />
                    <display value="Rekontaktierung weitere Erhebung" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="permit" />
            <period>
                <start value="2024-01-01T00:00:00+01:00" />
                <end value="2054-01-01T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="IDAT_zusammenfuehren_Dritte" />
                    <display value="Zusammenf&#252;hrung identifizierender Daten (IDAT) &#252;ber die unabh&#228;ngige Treuhandstelle mit Dritten Forschungspartnern, sofern dort eine Einwilligung vorliegt" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.4" />
                    <display value="IDAT zusammenfuehren Dritte" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-01-15T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_5J_retro_uebertragen" />
                    <display value="Krankenkassendaten (KKDAT) der letzten f&#252;nf Kalenderjahre vor Datum Unterschrift &#252;bertragen" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.11" />
                    <display value="KKDAT 5J retrospektiv uebertragen" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-01-15T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_5J_retro_speichern_verarbeiten" />
                    <display value="Retrospektive Krankenkassendaten (KKDAT) aus f&#252;nf Jahren vor Einwilligung speichern und codiert verarbeiten zu Zwecken med. Forschung in der verantwortlichen Stelle" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.12" />
                    <display value="KKDAT 5J retrospektiv speichern verarbeiten" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-01-15T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_5J_pro_wissenschaftlich_nutzen" />
                    <display value="Bereitstellung umcodierter prospektiver Krankenkassendaten (KKDAT) aus f&#252;nf Jahren ab Einwilligung zu Zwecken med. Forschung an ext. Forscher" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.17" />
                    <display value="KKDAT 5J prospektiv wissenschaftlich nutzen" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-01-15T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_5J_retro_wissenschaftlich_nutzen" />
                    <display value="Bereitstellung umcodierter retrospektiver Krankenkassendaten (KKDAT) f&#252;r wissenschaftliche Nutzung zu Zwecken med. Forschung an externe Forscher" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.13" />
                    <display value="KKDAT 5J retrospektiv wissenschaftlich nutzen" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-01-15T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="Rekontaktierung_weitere_Studien" />
                    <display value="Rekontaktierung bez&#252;glich Information zu neuen Forschungsvorhaben oder Studien" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.29" />
                    <display value="Rekontaktierung weitere Studien" />
                </coding>
            </code>
        </provision>
    </provision>
</Consent>

Beispiel 4: Consent mit Provisions zur Abbildung eines Widerrufsdokuments

<Consent xmlns="http://hl7.org/fhir">
    <id value="c6f32bcb-315d-4ce6-88d8-3c3ef5d5f379" />
    <meta>
        <lastUpdated value="2024-02-26T10:04:08.701+01:00" />
        <profile value="http://fhir.de/ConsentManagement/StructureDefinition/Consent" />
    </meta>
    <extension url="http://fhir.de/ConsentManagement/StructureDefinition/DomainReference">
        <extension url="domain">
            <valueReference>
                <reference value="ResearchStudy/1bf8568b-bfa4-49f4-8a3a-51024974012b" />
            </valueReference>
        </extension>
        <extension url="status">
            <valueCoding>
                <system value="http://hl7.org/fhir/publication-status" />
                <code value="active" />
            </valueCoding>
        </extension>
    </extension>
    <status value="active" />
    <scope>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/consentscope" />
            <code value="research" />
        </coding>
    </scope>
    <category>
        <coding>
            <system value="http://loinc.org" />
            <code value="57016-8" />
        </coding>
    </category>
    <category>
        <coding>
            <system value="http://fhir.de/ConsentManagement/CodeSystem/ResultType" />
            <code value="document" />
        </coding>
    </category>
    <category>
        <coding>
            <system value="http://fhir.de/ConsentManagement/ValueSet/TemplateType" />
            <code value="WITHDRAWAL" />
        </coding>
    </category>
    <patient>
        <reference value="Patient/6ae55815-07e8-4cbf-a900-5bccca739a7a" />
        <display value="studyPSN dic_810MT" />
    </patient>
    <dateTime value="2024-02-26T00:00:00+01:00" />
    <organization>
        <display value="MII" />
    </organization>
    <policy>
        <uri value="urn:oid:2.16.840.1.113883.3.1937.777.24.2.184" />
    </policy>
    <provision>
        <type value="deny" />
        <period>
            <start value="2024-02-26T00:00:00+01:00" />
        </period>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="IDAT_erheben" />
                    <display value="Erfassung neuer identifizierender Daten (IDAT)" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.2" />
                    <display value="IDAT erheben" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="MDAT_erheben" />
                    <display value="Erfassung medizinischer Daten (MDAT)" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.6" />
                    <display value="MDAT erheben" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="IDAT_bereitstellen_EU_DSGVO_konform" />
                    <display value="Herausgabe identifizierender Daten (IDAT) an unabh&#228;ngige Treuhandstelle zur weiteren Verarbeitung" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.5" />
                    <display value="IDAT bereitstellen EU DSGVO NIVEAU" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="Rekontaktierung_Ergebnisse_erheblicher_Bedeutung" />
                    <display value="Rekontaktierung des Betroffenen bei Ergebnissen von erheblicher Bedeutung" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.37" />
                    <display value="Rekontaktierung Ergebnisse erheblicher Bedeutung" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="MDAT_zusammenfuehren_Dritte" />
                    <display value="Zusammenf&#252;hrung medizinischer Daten (MDAT) mit Dritten Forschungspartnern, sofern dort eine Einwilligung vorliegt" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.9" />
                    <display value="MDAT zusammenfuehren Dritte" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="MDAT_speichern_verarbeiten" />
                    <display value="Speicherung und Verarbeitung von medizinischen codierten Daten zu Zwecken med. Forschung innerhalb der verantwortlichen Stelle (MDAT)" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.7" />
                    <display value="MDAT speichern, verarbeiten" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="Rekontaktierung_Zusatzbefund" />
                    <display value="Rekontaktierung bez&#252;glich Zusatzbefund im Rahmen der am Standort daf&#252;r entwickelten Prozesse und der im Nutzungsantrag angegebenen Bedingungen" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.31" />
                    <display value="Rekontaktierung Zusatzbefund" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="IDAT_speichern_verarbeiten" />
                    <display value="Speicherung und Verarbeitung identifizierender Daten (IDAT) zu Zwecken med. Forschung in der verantwortlichen Stelle" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.3" />
                    <display value="IDAT speichern, verarbeiten" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_5J_pro_speichern_verarbeiten" />
                    <display value="Prospektive Krankenkassendaten (KKDAT) aus f&#252;nf Jahren ab Einwilligung speichern und codiert verarbeiten zu Zwecken der med. Forschung in der verantwortlichen Stelle" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.16" />
                    <display value="KKDAT 5J prospektiv speichern verarbeiten" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="Rekontaktierung_Verknuepfung_Datenbanken" />
                    <display value="Rekontaktierung zur Verkn&#252;pfung von Patientendaten mit Daten anderer Datenbanken" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.27" />
                    <display value="Rekontaktierung Verkn&#252;pfung Datenbanken" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_KVNR_5J_pro_uebertragen" />
                    <display value="Erlaubnis zur prospektiven &#220;bermittlung der KVNr., MII-Pseudonym und Zeitraum Daten&#252;bermittlung (von: Datum Unterschrift; bis: max. 5 Kalenderjahre nach Unterschrift) an zust&#228;ndige Stelle" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.39" />
                    <display value="KKDAT 5J prospektiv uebertragen KVNR" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_KVNR_5J_retro_uebertragen" />
                    <display value="Erlaubnis zur retrospektiven &#220;bermittlung der KVNr., MII-Pseudonym und Zeitraum Daten&#252;bermittlung (von:5 Jahre vor Datum Unterschrift; bis: Datum Unterschrift) an zust&#228;ndige Stelle" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.38" />
                    <display value="KKDAT 5J retrospektiv uebertragen KVNR" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="MDAT_wissenschaftlich_nutzen_EU_DSGVO_konform" />
                    <display value="Bereitstellung umcodierter medizinischer Daten (MDAT) f&#252;r wissenschaftliche Nutzung zu Zwecken med. Forschung an externe Forscher" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.8" />
                    <display value="MDAT wissenschaftlich nutzen EU DSGVO NIVEAU" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_5J_pro_uebertragen" />
                    <display value="Prospektive Krankenkassendaten (KKDAT) f&#252;r f&#252;nf Kalenderjahre nach Datum Unterschrift &#252;bertragen" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.15" />
                    <display value="KKDAT 5J prospektiv uebertragen" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="Rekontaktierung_weitere_Erhebung" />
                    <display value="Rekontaktierung bez&#252;glich Erhebung zus&#228;tzlicher Daten" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.28" />
                    <display value="Rekontaktierung weitere Erhebung" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="IDAT_zusammenfuehren_Dritte" />
                    <display value="Zusammenf&#252;hrung identifizierender Daten (IDAT) &#252;ber die unabh&#228;ngige Treuhandstelle mit Dritten Forschungspartnern, sofern dort eine Einwilligung vorliegt" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.4" />
                    <display value="IDAT zusammenfuehren Dritte" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_5J_retro_uebertragen" />
                    <display value="Krankenkassendaten (KKDAT) der letzten f&#252;nf Kalenderjahre vor Datum Unterschrift &#252;bertragen" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.11" />
                    <display value="KKDAT 5J retrospektiv uebertragen" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_5J_retro_speichern_verarbeiten" />
                    <display value="Retrospektive Krankenkassendaten (KKDAT) aus f&#252;nf Jahren vor Einwilligung speichern und codiert verarbeiten zu Zwecken med. Forschung in der verantwortlichen Stelle" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.12" />
                    <display value="KKDAT 5J retrospektiv speichern verarbeiten" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_5J_pro_wissenschaftlich_nutzen" />
                    <display value="Bereitstellung umcodierter prospektiver Krankenkassendaten (KKDAT) aus f&#252;nf Jahren ab Einwilligung zu Zwecken med. Forschung an ext. Forscher" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.17" />
                    <display value="KKDAT 5J prospektiv wissenschaftlich nutzen" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy/MII" />
                    <code value="KKDAT_5J_retro_wissenschaftlich_nutzen" />
                    <display value="Bereitstellung umcodierter retrospektiver Krankenkassendaten (KKDAT) f&#252;r wissenschaftliche Nutzung zu Zwecken med. Forschung an externe Forscher" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.13" />
                    <display value="KKDAT 5J retrospektiv wissenschaftlich nutzen" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-02-26T00:00:00+01:00" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="Rekontaktierung_weitere_Studien" />
                    <display value="Rekontaktierung bez&#252;glich Information zu neuen Forschungsvorhaben oder Studien" />
                </coding>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.29" />
                    <display value="Rekontaktierung weitere Studien" />
                </coding>
            </code>
        </provision>
    </provision>
</Consent>

Beispiel 5: Consent mit Provision zur Abbildung eines Opt-Out-Einwilligungsdokuments

<Consent xmlns="http://hl7.org/fhir">
    <id value="43f993f6-012e-49fc-a7c0-97497ccbd33e" />
    <meta>
        <lastUpdated value="2024-02-26T10:04:08.701+01:00" />
        <profile value="http://fhir.de/ConsentManagement/StructureDefinition/Consent" />
    </meta>
    <extension url="http://fhir.de/ConsentManagement/StructureDefinition/DomainReference">
        <extension url="domain">
            <valueReference>
                <reference value="ResearchStudy/2e634a72-ea64-4991-92c1-842ae14e31a8" />
            </valueReference>
        </extension>
        <extension url="status">
            <valueCoding>
                <system value="http://hl7.org/fhir/publication-status" />
                <code value="active" />
            </valueCoding>
        </extension>
    </extension>
    <status value="active" />
    <scope>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/consentscope" />
            <code value="treatment" />
        </coding>
    </scope>
    <category>
        <coding>
            <system value="http://loinc.org" />
            <code value="57016-8" />
        </coding>
    </category>
    <category>
        <coding>
            <system value="http://fhir.de/ConsentManagement/CodeSystem/ResultType" />
            <code value="document" />
        </coding>
    </category>
    <category>
        <coding>
            <system value="http://fhir.de/ConsentManagement/ValueSet/TemplateType" />
            <code value="CONSENT-OPT-OUT" />
        </coding>
    </category>
    <patient>
        <reference value="Patient/6ae55815-07e8-4cbf-a900-5bccca739a7a" />
        <display value="studyPSN dic_810MT" />
    </patient>
    <dateTime value="2024-02-26T00:00:00+01:00" />
    <policy>
        <uri value="https://www.bundesgesundheitsministerium.de/elektronische-patientenakte" />
    </policy>
    <provision>
        <type value="permit" />
        <period>
            <start value="2024-02-26T00:00:00+01:00" />
        </period>
    </provision>
</Consent>

Beispiel 6: Consent mit Provision zur Abbildung eines Einwilligungsmoduls

<Consent xmlns="http://hl7.org/fhir">
    <id value="9790aa00-2059-43dd-adfb-b30908c92b48" />
    <meta>
        <lastUpdated value="2024-05-13T10:01:00+00:00" />
        <profile value="http://fhir.de/ConsentManagement/StructureDefinition/Consent" />
    </meta>
    <extension url="http://fhir.de/ConsentManagement/StructureDefinition/DomainReference">
        <extension url="domain">
            <valueReference>
                <reference value="ResearchStudy/d7a65ce8-2810-401a-b0db-70782a7b19a6" />
            </valueReference>
        </extension>
        <extension url="status">
            <valueCoding>
                <system value="http://hl7.org/fhir/publication-status" />
                <code value="active" />
            </valueCoding>
        </extension>
    </extension>
    <status value="active" />
    <scope>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/consentscope" />
            <code value="research" />
        </coding>
    </scope>
    <category>
        <coding>
            <system value="http://loinc.org" />
            <code value="59284-0" />
        </coding>
    </category>
    <!--  Consent-Kategorie resultType, hier: Modul  -->
    <category>
        <coding>
            <system value="http://fhir.de/ConsentManagement/CodeSystem/ResultType" />
            <code value="module" />
        </coding>
    </category>
    <category>
        <coding>
            <system value="http://fhir.de/ConsentManagement/CodeSystem/TemplateType" />
            <code value="CONSENT-OPT-IN" />
        </coding>
    </category>
    <patient>
        <reference value="Patient/9b4a702d-162c-428a-8c5d-8b98af21b693" />
    </patient>
    <dateTime value="2020-09-01" />
    <organization>
        <display value="Klinikum Musterstadt" />
    </organization>
    <sourceReference>
        <reference value="QuestionnaireResponse/02eac854-6a2e-48f9-88d7-edd04faff81c" />
    </sourceReference>
    <policy>
        <uri value="https://www.medizininformatik-initiative.de/sites/default/files/2020-04/MII_AG-Consent_Einheitlicher-Mustertext_v1.6d.pdf" />
    </policy>
    <provision>
        <type value="deny" />
        <period>
            <start value="2020-09-01" />
            <end value="2050-08-31" />
        </period>
        <provision>
            <type value="permit" />
            <period>
                <start value="2020-09-01" />
                <end value="2025-08-31" />
            </period>
            <code>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.6" />
                    <display value="MDAT_erheben" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="permit" />
            <period>
                <start value="2020-09-01" />
                <end value="2050-08-31" />
            </period>
            <code>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.7" />
                    <display value="MDAT_speichern_verarbeiten" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="permit" />
            <period>
                <start value="2020-09-01" />
                <end value="2050-08-31" />
            </period>
            <code>
                <coding>
                    <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.3" />
                    <code value="2.16.840.1.113883.3.1937.777.24.5.3.8" />
                    <display value="MDAT_wissenschaftlich_nutzen_EU_DSGVO_NIVEAU" />
                </coding>
            </code>
        </provision>
        <!-- 
      Dies ist ein Beispiel zur Veranschaulichung; der komplette Baum der
      hier als Beispiel genutzten MII-Policies umfasst weitere
      Provisions auf Level 2
     -->
    </provision>
</Consent>

Beispiel 7: Consent mit Provision zur Abbildung eines Widerspruchs

<Consent xmlns="http://hl7.org/fhir">
    <id value="d5346fc3-30a2-49ca-b2da-e254d220381d" />
    <meta>
        <lastUpdated value="2024-05-13T10:02:00+00:00" />
        <profile value="http://fhir.de/ConsentManagement/StructureDefinition/Consent" />
    </meta>
    <extension url="http://fhir.de/ConsentManagement/StructureDefinition/DomainReference">
        <extension url="domain">
            <valueReference>
                <reference value="ResearchStudy/d7a65ce8-2810-401a-b0db-70782a7b19a6" />
            </valueReference>
        </extension>
        <extension url="status">
            <valueCoding>
                <system value="http://hl7.org/fhir/publication-status" />
                <code value="active" />
            </valueCoding>
        </extension>
    </extension>
    <status value="active" />
    <scope>
        <coding>
            <system value="http://terminology.hl7.org/CodeSystem/consentscope" />
            <code value="research" />
        </coding>
    </scope>
    <category>
        <coding>
            <system value="http://loinc.org" />
            <code value="59284-0" />
        </coding>
    </category>
    <category>
        <coding>
            <system value="http://fhir.de/ConsentManagement/CodeSystem/ResultType" />
            <code value="document" />
        </coding>
    </category>
    <category>
        <coding>
            <system value="http://fhir.de/ConsentManagement/CodeSystem/TemplateType" />
            <code value="OBJECTION" />
        </coding>
    </category>
    <patient>
        <reference value="Patient/9b4a702d-162c-428a-8c5d-8b98af21b693" />
    </patient>
    <dateTime value="2024-05-13" />
    <organization>
        <display value="Klinikum Musterstadt" />
    </organization>
    <sourceReference>
        <reference value="QuestionnaireResponse/1eb81b1c-27d3-420c-96f0-033d33aa3d52" />
    </sourceReference>
    <policy>
        <uri value="https://beispiel.de/ePaFuerAlle" />
    </policy>
    <provision>
        <type value="deny" />
        <period>
            <start value="2024-05-13" />
        </period>
        <!--  Provisions auf Level 2 zur Konkretisierung; vgl. Hinweise im Text  -->
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-05-13" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="IDAT_erheben" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-05-13" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="MDAT_erheben" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-05-13" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="MDAT_speichern_verarbeiten" />
                </coding>
            </code>
        </provision>
        <provision>
            <type value="deny" />
            <period>
                <start value="2024-05-13" />
            </period>
            <code>
                <coding>
                    <system value="https://ths-greifswald.de/fhir/CodeSystem/gics/Policy" />
                    <code value="MDAT_wissenschaftlich_nutzen_EU_DSGVO_NIVEAU" />
                </coding>
            </code>
        </provision>
    </provision>
</Consent>

Consent